Pancreatic CancerNCT00885248
Integrated Positron Emission Tomography - Computed Tomography (PET-CT) in Patients With Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
In suspecting pancreatic cancer, dynamic phase pancreatic CT is the most effective tool in diagnosis and staging. In addition, magnetic resolution image, endoscopic ultrasonography, endoscopic retrograde pancreatography, angiography can be performed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The suspects of pancreatic cancer to visit Asan Medical Center in South Korea
Who may be able to join
- Pancreatic mass suspicious of pancreatic cancer
- No comorbidity, expected life expectancy less than 6 months
- Consent this study in letter
Who cannot join
- Refuse diagnostic and staging work-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Implication of Integrated PET-CT in the Patients With Pancreatic Cancer
In suspecting pancreatic cancer, dynamic phase pancreatic CT is the most effective tool in diagnosis and staging. In addition, magnetic resolution image, endoscopic ultrasonography, endoscopic retrograde pancreatography, angiography can be performed.
After introduction of functional image, PET has been suggested in the role of diagnosis and staging of pancreatic cancer. Furthermore, recently fused images of PET and CT were available.
In this study, the researchers evaluate the role of integrated PET-CT in patients with pancreatic cancer and analysis the cost-effectiveness of the integrated PET-CT.
Read the detailed description
Compared to dynamic phase pancreatic CT, integrated PET-CT will be evaluated for sensitivity, specificity and accuracy of diagnosing and staging pancreatic cancer while the gold standard for pancratic cancer is operative specimen. If the operation can't be performed, EUS-FNA of the pancreatic mass or lymph node and additional imaging modality will be preferred to laparotomy.
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, integrated PET-CT
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Staging of pancreatic cancer
Measured: 6 months after study start
Secondary outcomes (1)
Diagnosis of pancreatic cancer
Measured: 6 months after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885248
- Sponsor's protocol ID
- 2008-0623
- Status last verified
- Apr 2009
- First submitted
- 20 Apr 2009
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implication of Integrated PET-CT in the Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00885248
- Acronym / sponsor ID
- 2008-0623
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, integrated PET-CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In suspecting pancreatic cancer, dynamic phase pancreatic CT is the most effective tool in diagnosis and staging. In addition, magnetic resolution image, endoscopic ultrasonography, endoscopic retrograde pancreatography, angiography can be performed.
After introduction of functional image, PET has been suggested in the role of diagnosis and staging of pancreatic cancer. Furthermore, recently fused images of PET and CT were available.
In this study, the researchers evaluate the role of integrated PET-CT in patients with pancreatic cancer and analysis the cost-effectiveness of the integrated PET-CT.
Detailed description
Compared to dynamic phase pancreatic CT, integrated PET-CT will be evaluated for sensitivity, specificity and accuracy of diagnosing and staging pancreatic cancer while the gold standard for pancratic cancer is operative specimen. If the operation can't be performed, EUS-FNA of the pancreatic mass or lymph node and additional imaging modality will be preferred to laparotomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The suspects of pancreatic cancer to visit Asan Medical Center in South Korea
Key inclusion criteria (3 listed)
- Pancreatic mass suspicious of pancreatic cancer
- No comorbidity, expected life expectancy less than 6 months
- Consent this study in letter
Key exclusion criteria (1 listed)
- Refuse diagnostic and staging work-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Staging of pancreatic cancer
Time frame: 6 months after study start
1 secondary outcome
Diagnosis of pancreatic cancer
Time frame: 6 months after study start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staging of pancreatic cancer (time frame: 6 months after study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2009.